Ready to trade in the EU?

Life Cycle of a Biosimilar

Can your product be handled as a biosimilar from a regulatory perspective?

Are you aware of the differences in regulatory requirements in the USA/EU?

Have you fully considered then implication of any differences to the Reference Product?

Sound regulatory advice early on in the programme can:

Add value to your project for your Investors

Avoid wasting money on unnecessary trials

Reduce time to market significantly

Increase profits by having a longer unopposed sales period

Are you developing a ‘generic’ version of a novel biological medicine?

You are now in a race against time to make sure that you will be first to the market after patent expiry of the innovator product.

You can get ahead if you start thinking about Regulatory issues NOW

It is a common misconception that you only need to consider regulatory affairs when your development phase is complete". This could not be further from the truth because everything that you do from this stage onwards must be done to standards that satisfy regulatory authorities in your chosen markets.

Make sure that you have the regulatory resource and experience to get your candidate product to market ahead of the competition.

There’s no need to go it alone!

CambReg can help by:

Providing honest unbiased regulatory advice

Supplying information on latest relevant guidelines

Provide you with a full understanding of the regulatory framework

Recommend Experts in your field

Recommend Contract Houses for subsequent development.

Taking early advice on your development programme means early to market.

Only 1 out of 10,000 lead compounds make it to the market*.As somebody who has over 25 years’ experience in pharmaceutical R&D, I found the performance of Cambridge Regulatory Services Ltd to be way above average for regulatory affairs consultancies and would not hesitate to use their services again”.

(Jon Dickens - ENACT)

Make sure you can satisfy Health Authorities in the EU, USA and Japan with one data package.

Have you considered immunological properties to design your proof-of-concept studies?

Do your manufacturing standards comply with regulatory requirements?

Our biotech knowledge and experience can help you decide on your CMC strategies before you embark on your clinical programme.

Take advantage of our strong in-house CMC team headed by Dr Mike James (ex-MHRA assessor with more than 20 years' regulatory experience) and choose the most cost-effective route for your product

Non-Clinical Phase

At this stage you will be required to carry out intensive in vitro testing generally coupled with studies in various animal species.

Is one study enough to obtain the necessary PK, PD, toxicity and immunogenicity data?

Have you considered immunological properties to design your proof-of-concept studies?

Have you considered species specificity and other factors prior to your studies?

Do you need to assess toxicokinetics and recovery?

If you are unsure about any component of the non-clinical development, the solution is to outsource.

This will be a key element in getting the work done in an efficient and timely manner.

Our Services include:

Review of and advice on your non-clinical programme

Recommendation of contract houses for your pre-clinical studies

Recommendation of opinion leaders in your field

Arranging GLP Compliance Mock Inspections

Preparing your CTD Module 4

Authoring your Module 2 Overview and Summary

Using a pragmatic approach and good arguments, we could help you satisfy the regulators with a less costly and streamlined non-clinical programme.

Clinical Phase

In this most costly phase, it is vital to make sure that you are working with experts.

Mistakes at this juncture can be very expensive. Get us involved early on in your clinical phase programme and allow us to advise you on critical issues to consider which, if ignored, will be costly in terms of time.

Can you substitute confirmatory clinical trials with pharmacodynamic studies?

Have you considered obtaining Scientific Advicefrom the regulators for your immunogenicity issues?

Have you fully defined and justified your a priori equivalence margin?

Our Services:

In this busy phase we can help you get ahead with:

Clinical programme advice

CTA (Writing and Submission)

Ethics Committee Approval

Recommending opinion leaders

Recommending a CRO to execute your clinical trial programme

Mock GCP Inspections

Preparing and User Testing of Product Information (Labelling and Leaflets)

Authoring and Testing Subject Information Sheets (SIS)

Take advantage of our knowledge and experience during this important phase of your product development

Management of the procedure from Pre-Submission to Post-Approval Phase Commitments

Pre-procedural meeting

Pre-submission requests

Advice on Product Name

Eligibility requests for Accelerated / Conditional Approvals

Advice on fee waivers / reductions

Preparation for Pre-Approval Inspections (GMP / GCP)

Regulatory Submission Strategy

Do you know?

Which regulatory route(s) your product is eligible for?

What is the legal basis of your submission?

We can devise an optimum submission strategy that combines both your commercial and regulatory needs.

As you will have to submit your biosimilar EU dossier via the Centralised Procedure (CP), we can suggest ways in which you can get your product to the market faster (e.g. Accelerated / Conditional Approvals) and cheaper (fee waivers/ reductions)

Dossier Compilation and Procedure Management

Plan for early submission by building an eCTD dossier as you move through your development programme (saving 3-6 months).